MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL; Mesh, surgical, absorbable, staple line reinforcement

Model Number	NV-L-015G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3010668881-2026-00002.An anastomotic leak occurred.

• Brand Name: NEOVEIL
• Common Device Name: Mesh, surgical, absorbable, staple line reinforcement
• Manufacturer (Section D): GUNZE LIMITED; 46 natsumegaichi, aono; ayabe; kyoto, 623-8 513; JA 623-8513
• MDR Report Key: 25345058
• Report Number: 3012602431-2026-00051
• Device Sequence Number: 17465417
• Product Code: OXC
• UDI-Device Identifier: 04548366322481
• UDI-Public: 04548366322481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2026
• Report Date (Section F): 05/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NV-L-015G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/26/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/31/2026